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Visual Perceptual Learning Based Digital Therapeutics for Visual Field Defect After Stroke

Primary Purpose

Visual Fields Hemianopsia, Hemianopsia, Homonymous

Status
Active
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
VIVID Brain
No-treatment Control
Sponsored by
Nunaps Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Visual Fields Hemianopsia focused on measuring Visual field defect, Visual perceptual learning, Humphrey visual field

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 19 years and older
  • At least 3 months after brain disease related to visual field defect
  • Verified brain disease in visual pathway related to occipital lobe, parietal lobe, temporal lobe or etc. using CT or MRI
  • Brain disease induced visual field defect
  • Able to use the VR (Virtual Reality) device
  • Able to use the app with a smart phone
  • Patient/legally authorized representative has signed the informed consent form

Exclusion Criteria:

  • Complete hemianopsia
  • Epilepsy, photosensitivity, Parkinson's disease
  • Bilateral visual field defect
  • Hemispatial neglect
  • Ophthalmologic disorder that may interfere the trial. (Ptosis of Eyelid, Corneal Opacity, Diabetic Retinopathy, Glaucoma, Macular Degeneration etc.)
  • Inability to discontinue psychostimulants such as methylphenidate, modafinil, and amphetamine.
  • Candidate for carotid endarterectomy or stenting
  • Received ophthalmologic surgery or laser surgery within 3 months, except for the cataract surgery
  • Pregnant or breast feeding
  • Participating in other clinical trial
  • Any other condition that, in the opinion of the investigator, precludes participation in the trial

Sites / Locations

  • Korea University Ansan Hospital
  • Hallym University Sacred Heart Hospital
  • Daejeon Eulji University Medical Center
  • Inje University Ilsan Paik Hospital
  • Seoul National University Bundang Hospital
  • Asan Medical Center
  • Chung-Ang University Hospital
  • Konkuk University Hospital
  • Samsung Medical Center
  • The Catholic University of Korea Seoul St. Mary's Hospital
  • The Catholic University of Korea Yeouido St. Mary's Hospital
  • Ulsan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

VIVID Brain

No-treatment Control

Arm Description

VIVID Brain, 5 times a week for 12 weeks

No-treatment is administered during control period.

Outcomes

Primary Outcome Measures

The sum of improved areas compared to baseline in the whole field
The sum of areas where sensitivity increased by more than 6 dB compared to baseline in the whole field measured by Humphrey visual field test. The improved area ranges between 0 and 2,736 degree^2, of which larger area indicates better outcome.

Secondary Outcome Measures

The sum of improved areas compared to baseline in the affected hemi-field
The sum of areas where sensitivity increased by more than 6 dB compared to baseline in the affected hemi-field measured by Humphrey visual field test.
Changes in perimetric mean deviation relative to baseline in the whole field
Changes in perimetric mean deviation relative to baseline in the whole field measured by Humphrey visual field test.
Changes in mean total deviation relative to baseline in the affected hemi-field
Changes in mean total deviation relative to baseline in the affected hemi-field measured by Humphrey visual field test.

Full Information

First Posted
August 31, 2022
Last Updated
October 4, 2023
Sponsor
Nunaps Inc
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1. Study Identification

Unique Protocol Identification Number
NCT05525949
Brief Title
Visual Perceptual Learning Based Digital Therapeutics for Visual Field Defect After Stroke
Official Title
Treatment of Homonymous Visual Loss With Digital Therapeutics, VIVID Brain, Visual Perceptual Learning Device (HOGWAND Trial) : Multi Center, Randomized, Single-blind (Evaluator), Superiority Prove, Prospective Confirmatory Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 19, 2022 (Actual)
Primary Completion Date
August 11, 2023 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nunaps Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study evaluates the efficacy of visual perceptual learning for the treatment of visual field defect caused by brain disease. Half of participants will receive visual perceptual training using the VIVID Brain. The other half will not receive any training because there is no standard treatment for visual field defect caused by brain disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visual Fields Hemianopsia, Hemianopsia, Homonymous
Keywords
Visual field defect, Visual perceptual learning, Humphrey visual field

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VIVID Brain
Arm Type
Experimental
Arm Description
VIVID Brain, 5 times a week for 12 weeks
Arm Title
No-treatment Control
Arm Type
Other
Arm Description
No-treatment is administered during control period.
Intervention Type
Device
Intervention Name(s)
VIVID Brain
Intervention Description
Participants receive visual perceptual training using the VIVID Brain software.
Intervention Type
Other
Intervention Name(s)
No-treatment Control
Intervention Description
No-treatment is administered during control period.
Primary Outcome Measure Information:
Title
The sum of improved areas compared to baseline in the whole field
Description
The sum of areas where sensitivity increased by more than 6 dB compared to baseline in the whole field measured by Humphrey visual field test. The improved area ranges between 0 and 2,736 degree^2, of which larger area indicates better outcome.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
The sum of improved areas compared to baseline in the affected hemi-field
Description
The sum of areas where sensitivity increased by more than 6 dB compared to baseline in the affected hemi-field measured by Humphrey visual field test.
Time Frame
12 weeks
Title
Changes in perimetric mean deviation relative to baseline in the whole field
Description
Changes in perimetric mean deviation relative to baseline in the whole field measured by Humphrey visual field test.
Time Frame
12 weeks
Title
Changes in mean total deviation relative to baseline in the affected hemi-field
Description
Changes in mean total deviation relative to baseline in the affected hemi-field measured by Humphrey visual field test.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 19 years and older At least 3 months after brain disease related to visual field defect Verified brain disease in visual pathway related to occipital lobe, parietal lobe, temporal lobe or etc. using CT or MRI Brain disease induced visual field defect Able to use the VR (Virtual Reality) device Able to use the app with a smart phone Patient/legally authorized representative has signed the informed consent form Exclusion Criteria: Complete hemianopsia Epilepsy, photosensitivity, Parkinson's disease Bilateral visual field defect Hemispatial neglect Ophthalmologic disorder that may interfere the trial. (Ptosis of Eyelid, Corneal Opacity, Diabetic Retinopathy, Glaucoma, Macular Degeneration etc.) Inability to discontinue psychostimulants such as methylphenidate, modafinil, and amphetamine. Candidate for carotid endarterectomy or stenting Received ophthalmologic surgery or laser surgery within 3 months, except for the cataract surgery Pregnant or breast feeding Participating in other clinical trial Any other condition that, in the opinion of the investigator, precludes participation in the trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gyeong-Moon Kim, MD, PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Korea University Ansan Hospital
City
Ansan
Country
Korea, Republic of
Facility Name
Hallym University Sacred Heart Hospital
City
Anyang
Country
Korea, Republic of
Facility Name
Daejeon Eulji University Medical Center
City
Daejeon
Country
Korea, Republic of
Facility Name
Inje University Ilsan Paik Hospital
City
Goyang
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Chung-Ang University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Konkuk University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic University of Korea Seoul St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic University of Korea Yeouido St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Ulsan University Hospital
City
Ulsan
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Visual Perceptual Learning Based Digital Therapeutics for Visual Field Defect After Stroke

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